ARCHIVED — Vol. 148, No. 42 — October 18, 2014

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Regulations Amending the Medical Devices Regulations

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

This Regulatory Impact Analysis Statement (RIAS) addresses two issues with respect to the regulation of medical devices: (1) non-corrective contact lenses; and (2) the labelling of Class II medical devices, which are low-risk devices, such as surgical gloves, scalpels, and syringes.

Non-corrective contact lenses

In October 2011, the proposed legislation to deem non-corrective (decorative) contact lenses medical devices was introduced in Parliament with Private Member’s Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses). This Act received royal assent on December 14, 2012. Once this Act comes into force, these products would immediately become subject to the requirements of the Medical Devices Regulations (the Regulations). However, when non-corrective contact lenses have no accompanying therapeutic effects, these products would not meet the effectiveness requirements set out in the Regulations. Consequently, this regulatory amendment would exempt these products from the effectivenessrequirements that would not be applicable.

Class II medical device labelling

In Canada, medical devices are classified into one of four classes of increasing risk (Classes I to IV) by means of rules set out in the Medical Devices Regulations. The identification of a risk class for a device is largely determined by the product labelling. For Class II devices, however, a manufacturer does not currently need to provide a copy of the product label with a devicelicence application. Instead, only an attestation that the label complies with the requirements of the Regulations is required for a Class II devicelicence application. This practice has often resulted in the misclassification of certain medical devices into a lower-risk class, which does not require the same degree of regulatory scrutiny as that of devices in higher-risk classes. The inconsistencies between the content on the medical device label and the content in the device application could lead to potential health risks. As an example, a device labelled with false and misleading claims could prove harmful to the patient by not providing the anticipated treatment. Additionally, some medical device labels have been found not to meet the labelling requirements stated in the Regulations.

Background

Non-corrective contact lenses

Contact lenses are used primarily to correct vision defects by changing how light is refracted, that is, how it is focussed onto the retina of the eye. This is accomplished by varying the thickness and/or curvature of the lens. A contact lens of equal thickness across its surface is referred to as a non-corrective lens since it has no refractive power. Non-corrective contact lenses are frequently used by consumers for decorative purposes in order to change the appearance of the eye, such as the colour of the iris or the perceived shape of the pupil. These products have no therapeutic effect; therefore, they do not meet the current definition of a device under the Food and Drugs Act.

Non-corrective lenses may also be used for therapeutic purposes, such as when bandage lenses are used to treat damaged corneas. However, non-corrective contact lenses with a therapeutic effect already meet the definition of a device under the Food and Drugs Act, which means that they are outside the scope of this proposed regulatory amendment. Therefore,for the remainder of this document, “non-corrective contact lenses” refers to noncorrective contact lenses that have no therapeutic effect.

In 2003, Health Canada published the report entitled Human Health Risk Assessment of Cosmetic Contact Lenses. This report concluded that the health hazards associated with non-corrective contact lenses are the same as those associated with corrective lenses. Potential health hazards include scratching of the cornea during the insertion of a contact lens, and conjunctivitis or corneal ulcers caused by bacterial or viral contamination of a contact lens. (see footnote 1) Since 2002, Health Canada has received three incident reports involving corneal scratches and ulcers in patients who have used these products.

Non-corrective contact lenses are currently subject to the Canada Consumer Product Safety Act. Consequently, a licence from Health Canada is not required prior to the non-corrective contact lenses being imported into or sold in Canada. Once Bill C-313 comes into force, non-corrective lenses would be deemed devices under the Food and Drugs Act and would immediately become subject to the existing applicable requirements under the Medical Devices Regulations. Non-corrective contact lenses would be classified as Class II medical devices based on the existing Schedule 1, Rule 2(1), of the Regulations, as is currently the case for corrective contact lenses. As with all Class II device manufacturers, the device manufacturer would be required to hold a medical device licence prior to the non-corrective contact lenses being sold or imported into Canada. These products would also be required to be manufactured in compliance with the Canadian national standard for a quality system (CAN/CSA ISO 13485:2003). A quality system used to manufacture non-corrective contact lenses would have to be certified as being compliant with this standard by a registrar recognized by Health Canada. All importers and distributors of non-corrective contact lenses would need to hold a medical deviceestablishment licence; however, manufacturers and retailers would not be required to hold an establishment licence for Class II medical devices. The intention of the proposed regulatory amendment described below is to ensure that Health Canada’s regulatory oversight of non-corrective contact lenses respects the distinct nature of these products by exempting them from current legal requirements for effectiveness.

Class II medical device labelling

Nearly 30% of all Class II medical device licence applications have been found to contain vague and unclear information on the medical conditions, purposes, and uses for which the device was manufactured. One example is a reusable endoscope that without adequate instructions could result in improper cleaning between its uses. These situations have necessitated that Health Canada request additional information, usually a copy of the device label. Copies of actual labels have been requested for approximately 70% of all Class II medical device licence applications. These requests slow down the licensing process for this class of medical device. Additionally, in 10% of the cases where the label has been requested, the device in question was found to be misclassified and subsequently reclassified as a higher-risk Class III device. In cases where the label was not requested, between 20 and 30% of the devices have been subsequently discovered, during routine post-market inspections, to be incorrectly classified at a lower-risk class.

Finally, the information on approximately half of all Class II labels requested under the Regulations has been found to be deficient. Deficiencies have included inconsistencies with what was provided in the corresponding medical device licence application, missing basic administrative information (such as name, address, and catalogue number), and/or instructions for use that were incomplete or incorrect. These labelling deficiencies may not necessarily be related to device classification; some Class II devices are simply improperly labelled.

Objectives

The objective of the proposed Regulations for non-corrective contact lenses is to enable proportional regulatory oversight with regard to the manufacture and safe use of non-corrective lenses, without imposing an undue burden on the manufacturer. Specifically, the proposed amendments would exempt non-corrective contact lenses from effectiveness requirements but would allow for the application of the same safety, quality and labelling standards to all contact lenses sold in Canada.

The regulation with respect to labelling of Class II medical devices is intended to address concerns of (1) non-compliant labelling, thereby ensuring, prior to the sale of a device in Canada, that the claims and instructions for use of the device are accurate and complete; and (2) inappropriate risk classification of medical devices, so that the level of oversight applied to a device is proportional to the risk presented by its use. In addition, the proposed Regulations would remove potential delays in the licensing process for Class II devices that result from requests for copies of labels that were not provided voluntarily, enabling more timely access to these products.

Description

This proposal would introduce two sets of amendments to the Medical Devices Regulations, both involving the licence application requirements for Class II medical devices.

The first amendment would address the absence of therapeutic effect in non-corrective contact lenses. With their being deemed devices under the Food and Drugs Act, non-corrective contact lenses would be subject to all of the licensing requirements for Class II devices under the Medical Devices Regulations. However, an exemption would be made so that the manufacturers of noncorrective contact lenses would not be required to demonstrate the therapeutic effectiveness of these products. The proposed amendments to the Medical Devices Regulations and to the Food and Drugs Act would come into force at the same time.

The second amendment to the Medical Devices Regulations would require manufacturers of all Class II devices to submit a copy of the product label as part of the Class II medical device licence application.

“One-for-One” Rule

The “One-for-One” Rule would not apply to this proposal. The intent of the first regulatory amendment is to exempt manufacturers of non-corrective contact lens from the Class II device requirements to demonstrate therapeutic effectiveness. In addition, the proposed change in requirements for Class II device labelling involves the provision of a product label for which an attestation of regulatory compliance would have already been made. This would not change the administrative costs to business. Furthermore, this could reduce compliance costs by preventing possible delays in the filing process caused when ensuing requests are made by Health Canada for information already prepared by the manufacturer.

Small business lens

The small business lens does not apply as there are no incremental costs associated with this proposal.

Consultation

Stakeholders affected by the proposed amendment for noncorrective contact lenses include Canadian consumers, health care professionals, and provincial and territorial health regulators, and manufacturers, importers, distributors, and retailers of these products.

When Bill C-313 was presented to the House of Commons Standing Committee on Health in February 2012 and to the Standing Senate Committee on Social Affairs, Science and Technology in November 2012, the witnesses included representatives from three eye-care professional associations and one industry stakeholder. The eye-care professional associations all supported the proposed regulatory amendment, citing the health hazards associated with non-corrective lenses and the need for the same level of oversight for these products as currently exists for corrective lenses. The industry stakeholder expressed concern that regulation of non-corrective lenses could lead to an increase of the retail cost of these products and thus encourage consumers to seek out less expensive, unlicensed non-corrective lenses on the Internet. It is the position of Health Canada that, even if some consumers choose to purchase unlicensed products, the regulation of non-corrective lenses as Class II medical devices would provide a net benefit to the overall health and safety of Canadians.

A Notice of Intent that outlined this amendment was published in the Canada Gazette, Part I, on August 10, 2013. This is available online at http://gazette.gc.ca/rp-pr/p1/2013/2013-08-10/html/notice-avis-eng.html. No comments were received in the intervening time period.

With regard to Class II labelling requirements, Health Canada has communicated its intention to proceed with this regulatory amendment to Canada’s Medical Technology Companies (MEDEC), and no objections have been raised. Over the past several years, Health Canada has also presented the proposal to stakeholders at various technical workshops. This has resulted in approximately 70% of the manufacturers of medical devices in Canada having been notified of this proposal. No objections have been subsequently raised.

A 75-day comment period follows the publication of this regulatory proposal in the Canada Gazette, Part I. During this time period, interested parties are encouraged to provide their comments to the point of contact indicated at the end of this RIAS.

Rationale

Following a review of the available evidence, Health Canada has concluded that both corrective and non-corrective contact lenses carry similar potential risks of eye injury since they interact with the eye in the same way. While Bill C-313 would effectively standardize the regulation of all contact lenses and minimize the potential risks of harm, the proposed regulatory amendments would recognize the distinct nature of non-corrective lenses by exempting them from the inapplicable therapeutic effectiveness requirements of the Medical Devices Regulations.

The proposed regulatory amendment for Class II labelling requirements would result in no additional cost to Class II medical device manufacturers. Manufacturers must currently attest to having a completed label when their device licence application is filed with Health Canada. Manufacturers would benefit from the proposed regulatory amendment since delays in screening Class II medical device licence applications, due to follow-up requests for labels or other additional information, would likely be eliminated. Likewise, consumers would benefit from knowing that all medical devices are subject to an appropriate level of regulatory scrutiny relative to their risk classification, and that Class II medical device labels consistently meet the requirements of the Regulations.

Implementation, enforcement and service standards

With the deeming of non-corrective contact lenses as devices under the Food and Drugs Act, these products would be classified as Class II medical devices and subject to the labelling and licensing requirements for this class of devices, as set out in the Regulations. As part of the product licensing of non-corrective contact lenses, manufacturers would be required to hold a quality systems certificate issued by recognized third party auditing organizations called the Canadian Medical Devices Conformity Assessment System (CMDCAS). Distributors and importers of non-corrective contact lenses would be required to hold a medical device establishment licence. Existing guidance documents would be updated to provide additional information on regulatory compliance to manufacturers, distributors and importers of non-corrective contact lenses.

Health Canada charges user fees for activities performed when regulating medical devices. The Fees in Respect of Drugs and Medical Devices Regulations set out the respective fees for examining and renewing a Class II medical device licence application and an establishment licence application. The user fees to process device and establishment licence applications for non-corrective lenses would be applicable upon the coming into force of the amended Food and Drugs Act and these products being deemed as devices under this Act.

The proposed amendment for Class II medical device labelling would not alter the existing compliance mechanisms under the provisions of the Food and Drugs Act and the Medical Devices Regulations, enforced by the Health Products and Food Branch Inspectorate.

Coming into force

With regard to non-corrective contact lenses, the concurrent coming into force of the proposed amendments to the Medical Devices Regulations and the Food and Drugs Act would be delayed for 12 months following publication of the regulatory proposal in Canada Gazette, Part II, in order to meet Canada’s obligations on technical barriers to trade, and to allow manufacturers of non- corrective contact lenses to bring their operations into compliance with the new requirements.

The amended Regulations to address Class II device labelling would come into force on the day on which they are registered.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act(see footnote b), proposes to make the annexed Regulations Amending the Medical Devices Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Danielle Lozon, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (fax: 613-941-7104; email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, October 9, 2014

JURICA ČAPKUNAssistant Clerk of the Privy Council

REGULATIONS AMENDING THE MEDICAL DEVICES REGULATIONS

AMENDMENTS

1. (1) The definition “safety and effectiveness requirements” in section 1 of the Medical Devices Regulations(see footnote 2) is repealed.

(2) Section 1 of the Regulations is amended by adding the following in alphabetical order:

“applicable requirements of sections 10 to 20” means

(a) in respect of a decorative contact lens, the requirements set out in section 10, subsections 11(2) and 12(2) and sections 13 to 17; and

(b) in respect of any other medical device, the requirements set out in section 10, subsections 11(1) and 12(1) and sections 13 to 20. (exigences applicables prévues aux articles 10 à 20)

“decorative contact lens” means a device referred to in section 2.1 of the Act; (lentilles cornéennes à but esthétique)

2. Sections 11 and 12 of the Regulations are replaced by the following:

11. (1) A medical device other than a decorative contact lens shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.

(2) A decorative contact lens shall not adversely affect the health or safety of a user, except to the extent that a possible adverse effect of the device constitutes a risk that is compatible with a high level of protection of health and safety.

12. (1) A medical device other than a decorative contact lens shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.

(2) A decorative contact lens shall perform as intended by the manufacturer.

3. (1) Paragraph 21(1)(h) of the English version of the Regulations is replaced by the following:

(h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use;

(2) Paragraph 21(1)(i) of the Regulations is replaced by the following:

(i) the directions for use, unless directions are not required

(i) in the case of a decorative contact lens, for the device to be used safely, and

(ii) in the case of any other medical device, for the device to be used safely and effectively; and

4. (1) Paragraph 32(2)(d) of the Regulations is replaced by the following:

(d) a copy of the device label;

(2) Paragraph 32(3)(g) of the French version of the Regulations is replaced by the following:

g) une copie de l’étiquette de l’instrument;

(3) Paragraph 32(4)(o) of the French version of the Regulations is replaced by the following:

o) une copie de l’étiquette de l’instrument;

5. Paragraph 34(f) of the Regulations is replaced by the following:

(f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

6. Paragraph 45(e) of the Regulations is replaced by the following:

(e) for each manufacturer, in respect of a medical device other than a decorative contact lens, the medical specialities in respect of which the device is imported or distributed;

7. The Regulations are amended by replacing “safety and effectiveness requirements” with “applicable requirements of sections 10 to 20” in the following provisions:

(a) subsection 9(1);

(b) subsection 25(1) and paragraphs (2)(b) and (3)(b);

(c) paragraphs 32(2)(b) and (c), (3)(d) and (f) and (4)(d), (h) and (i);

(d) paragraph 33(1)(b) and subsection (2);

(e) subsection 35(1);

(f) the portion of subsection 36(1) before paragraph (a) and paragraph (2)(a);

(g) paragraph 37(b);

(h) subsection 38(2);

(i) section 39; and

(j) paragraphs 40(1)(d) and (e).

COMING INTO FORCE

8. (1) These Regulations, other than section 4, come into force on the day on which An Act to amend the Food and Drugs Act (non-corrective contact lenses), chapter 25 of the Statutes of Canada, 2012, comes into force.

(2) Section 4 comes into force on the day on which these Regulations are registered.